Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.

Septodont

Status: Enrolling

Conditions: Root Canal Obturation

Treatments: Device: BioRootTM RCS

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05247138

BIOR 2021-04

Details and patient eligibility

About

The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Participants will be followed prospectively at 5 and 10 years after root canal treatment.

Clinical data, radiographic data, adverse events (safety) and device performance will be collected by the dentist from the inclusion visit until the end of the study.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient, male or female, > 18 years of age at the time of inclusion in the study.
• Patient who had a non-surgical root canal treatment with BioRootTM RCS, in a context of an endodontic treatment, or retreatment, 5 years (± 6 months) ago.
• All roots of the investigational teeth were treated with BioRootTM RCS.
• Having a documented retro-alveolar radiography immediately after root canal obturation.
• Patient affiliated or beneficiary of a social security system.
• Patient has signed his/her informed consent form.

Exclusion criteria

• History of malignant tumors in the 5 years prior to the root canal treatment.
• Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.).
• Patient who developed a systemic pathology after the root canal treatment with BioRootTM RCS.
• The Root canal treatment with BioRootTM RCS is on a wisdom tooth.
• Tooth presenting an advanced periodontal disease (parodontal pocket ≥ 5mm or bone loss ≥ 50%).